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Cephalon's Myotrophin

Executive Summary

Last shipments of mecasermin for amyotrophic lateral sclerosis will be sent to Treatment IND patients at the end of December. The T-IND stopped enrolling late in 1998; 159 of the original 400 patients selected by lottery for the trial remain on drug. Cephalon is trying to get an FDA waiver to allow it to send a several month supply to patients in its last shipment. A Nov. 19 letter to patients and prescribers cited "the inability of the companies to bear the expense of the program without a reasonable prospect of near-term approval." A Phase III trial conducted by Japanese partner Kyowa Hakko Kogyo has been completed and Cephalon has met with FDA concerning what efficacy analyses would be required to support licensure of the "potentially approvable" drug

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